Roche,  a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics, has announced topline results of EMILIA, the first randomised phase III study of trastuzumab emtansine (T-DM1).  The study enrolled people with HER2-positive metastatic breast cancer (mBC) who had previously received treatment with Herceptin and a taxane (chemotherapy).  

The study showed people who received trastuzumab emtansine lived significantly longer without their disease getting worse (progression-free survival, PFS) compared to those who received lapatinib plus Xeloda (capecitabine).  

Final results for overall survival (OS), a co-primary efficacy endpoint of EMILIA, are not yet mature.  The safety profile of trastuzumab emtansine was consistent with that seen in previous studies.  These data will be submitted for presentation at an upcoming medical meeting.

Trastuzumab emtansine is an investigational medicine known as an antibody-drug conjugate (ADC).  It is comprised of the antibody trastuzumab and the chemotherapy agent DM1 attached together using a stable linker.  It is designed to target and inhibit HER2 signaling and deliver the chemotherapy directly inside HER2-positive cancer cells. Trastuzumab emtansine reinforces Roche's personalized healthcare approach of developing targeted medicines to fight cancer.

“Trastuzumab emtansine represents a new approach for the treatment of patients with HER2-positive breast cancer that comes from our decades of research on the HER pathway,”  said Hal Barron, M.D., chief medical officer and head, global product development.  “We are excited about the EMILIA results because trastuzumab emtansine is our first antibody drug conjugate and it may help people who still need more treatment options for this aggressive disease. We will work to submit these data to regulatory authorities as quickly as possible.”

Based on these findings, Roche plans to submit a Marketing Authorisation Application to the European Medicines Agency (EMA) this year for trastuzumab emtansine in HER2-positive mBC.  In addition, Genentech plans to submit a Biologics License Application for trastuzumab emtansine to the U.S. Food and Drug Administration (FDA) this year for the same indication.

EMILIA (TDM4370g/BO21977) is an international, phase III, randomised, open-label study comparing trastuzumab emtansine alone to lapatinib in combination with Xeloda in 991 people with HER2-positive mBC whose disease progressed after initial treatment with Herceptin and a taxane-based chemotherapy.

Trastuzumab emtansine (T-DM1) is an ADC being studied in HER2-positive cancers.  Trastuzumab emtansine is designed to inhibit HER2 signaling and deliver the chemotherapy agent DM1 directly inside  HER2-positive cancer cells.  Trastuzmab emtansine offers both the potential benefits of trastuzumab and the unique targeted delivery of chemotherapy, which may result in improved efficacy and fewer adverse events.  Trastuzumab emtansine binds to the HER2-positive cancer cells, and is thought to block out-of-control signals that make the cancer grow while also calling on the body's immune system to attack the cancer cells. Once trastuzumab emtansine is absorbed into those cancer cells, it is designed to destroy them by releasing the DM1.

Genentech, a member of the Roche Group, licenses technology for trastuzumab emtansine under an agreement with ImmunoGen, Inc.